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| ANI Pharmaceuticals, Inc.: ANI Pharmaceuticals Announces Intent to Appeal Rulings in CG Oncology Matter | Trial court denied Company's motion for a new trial and judgment as a matter of law for unjust enrichmentANI intends to appeal rulings to the Delaware Supreme Court and continue to seek to recover... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Reports Positive First Results from CORE-008 Cohort CX Phase 2 Trial Evaluating Intravesical Combination Therapy in High-Risk BCG-Exposed and BCG-Unresponsive Patients | - High CR rates at any time observed in the CIS-containing population with 85.7% and 92.3% in the ITT population and Efficacy Evaluable population, respectively - High-Grade - EFS in the overall intention-to-treat... ► Artikel lesen |
| CG Oncology Inc.: CG Oncology Reports First Quarter 2026 Financial Results and Provides Business Updates | Following alignment discussions with FDA, BLA completion for HR BCG-unresponsive NMIBC is expected fourth quarter 2026 PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant... ► Artikel lesen |
| Relay Therapeutics, Inc.: Relay Therapeutics Announces Pricing of Public Offering of Common Stock | CAMBRIDGE, Mass., May 20, 2026 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies... ► Artikel lesen |
| Relay Therapeutics, Inc.: Relay Therapeutics Announces Initial Clinical Data Demonstrating That Zovegalisib Has Potential for Differentiated Safety and Efficacy in Patients with PIK3CA-Driven Vascular Anomalies | Promising initial efficacy data with 60% volumetric response rate across doses and 29%* at the lowest tested dose of 100mg twice daily (BID) with all patients ongoing Interim investigator- and patient-reported... ► Artikel lesen |
| Relay Therapeutics, Inc.: Relay Therapeutics Reports First Quarter 2026 Financial Results and Corporate Updates | FDA Breakthrough Therapy designation granted to zovegalisib for PIK3CA-mutant, HR+/HER2- advanced breast cancer, the Phase 3 ReDiscover-2 trial population in 2L breast cancer Presented zovegalisib... ► Artikel lesen |
| Dyne Therapeutics, Inc.: Dyne Therapeutics Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for DYNE-302 in Facioscapulohumeral Muscular Dystrophy (FSHD) | - Company's third program to enter clinical development leveraging FORCE platform with the goal of delivering functional improvement in rare neuromuscular disease - WALTHAM, Mass., July 28, 2026 (GLOBE... ► Artikel lesen |
| Dyne Therapeutics, Inc.: Dyne Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD) | - Priority Review granted; PDUFA target action date set for January 21, 2027 - - Submission for Accelerated Approval based on dystrophin as a surrogate endpoint - - In the registrational expansion... ► Artikel lesen |
| Dyne Therapeutics, Inc.: Dyne Therapeutics Announces Expanded Debt Facility of Up To $400 Million with Hercules Capital, Inc. | - Up to $125 million in additional borrowing capacity provides further strategic flexibility - - $50 million of additional capacity funded at amendment closing - WALTHAM, Mass., June 17, 2026 (GLOBE... ► Artikel lesen |
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